Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Section 1 Identification of the substance/mixture and of the
company/undertaking
1.1 Product identifiers
Product Name:
Item number:
STAT-Intra Operative-Intact PTH kit
4K-IPT-00
1.2 Relevant identified uses of the substance or mixture and uses advised against
Identified uses:
For In Vitro Diagnostics use only.
1.3 Details of the supplier of the safety data sheet
Legal Manufacturer:
Emergency Phone No.:
Future Diagnostics Solutions B.V.
Nieuweweg 279
6603 BN Wijchen
The Netherlands
Tel: +31 (0) 24 6452900
Monday to Friday, during office hours (UTC+1:00)
[email protected]
EU: 112
US: 911
Section 2 Hazards Identification
2.1 Classification of the substance or mixture
Classification according to EU regulation 1272/2008
Standards (S0, S1, S2, S3, S4 and S5): Considered non-hazardous
Controls (C1 and C2):
Considered non-hazardous
Wash solution:
Considered non-hazardous
RTU (Ready to use) plate:
Considered non-hazardous
NC (Non coated) plate:
Considered non-hazardous
Activator 1:
Skin corrosive category 1B, H314
Activator2:
Considered non-hazardous
For the full text of the H-Statements mentioned in this Section, see section 16.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
2.2 Labeling elements
Labeling according EU regulation 1272/2008
Activator 1
Pictogram:
GHS05
Signal Word:
Danger
Hazard statement:
H314:
Causes severe skin burns and eye damage
Precautionary statement(s)
P280:
P303+P361+P353:
P305+P351+P338:
P310:
Wear protective gloves/protective clothing/eye protection/face
protection
IF ON SKIN (or hair): Remove/Take off immediately all contaminated
clothing. Rinse skin with water/shower.
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER or doctor/physician.
2.3 Other hazards
Standards (S0, S1, S2, S3, S4 and S5): Contains Sodium Azide (NaN3, <0.1%) and material from
human origin. Though each donor was tested and found
negative for HBV, HCV and HIV, complete absence of these of
other infectious reagents can never be assured. Therefore
these materials should be regarded as potentially infectious.
Controls (C1 and C2):
Contains Sodium Azide (NaN3, <0.1%) and material from
human origin. Though each donor was tested and found
negative for HBV, HCV and HIV, complete absence of these of
other infectious reagents can never be assured. Therefore
these materials should be regarded as potentially infectious.
Wash solution:
Contains Sodium Azide (NaN3, <0.1%).
RTU-plate:
Contains material of animal origin and should be considered
potentially infectious.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Section 3 Composition/Information of ingredients
3.1. Substance
Not applicable
3.2. Mixture
Synonyms:
Chemical name:
Activator 1
Sodium hydroxide solution
Hazardous ingredients
Sodium hydroxide
Cas No.
1310-73-2
EG No.
215-185-5
Art. No.
Reach. No.
%(w/w)
Classification according to
Regulation (EC) 1272/2008
3C-UVL-01
01211945789227-XXXX
4
Skin Corr. 1A H314
For the full text of the H-statements mentioned in this Section, see Section 16.
Section 4 First Aid Measures
4.1 Description of first aid measurers
Skin Contact:
In case of skin contact, wash thoroughly with soap and water of at least 15 minutes. Remove
contaminated clothing and shoes. If pain or irritation occurs, obtain medical attention.
Eye Contact:
If product enters eyes, wash gently under running water for 15 minutes or longer, making
sure that the eyelids are held open. If pain or irritation occurs, obtain medical attention.
Ingestion:
Never give anything by mouth to an unconscious person. If ingested, wash mouth out with
water and seek medical attention.
Inhalation:
If product is inhaled, move exposed individual to fresh air. If individual is not breathing,
begin artificial respiration immediately and obtain medical attention.
4.2 Most important symptoms and effects, both acute and delayed
Activator 1 causes severe skin burns and eye damage
4.3 Indication of any immediate medical attention and special treatment needed
For any immediate medical attention see section 4.1.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Section 5 Fire Fighting Measures
5.1 Extinguishing media
Suitable extinguishing media:
Use extinguishing media suitable for surrounding fire. Use water spray, alcohol-resistant foam, dry
chemical or carbon dioxide.
5.2 Special hazards arising from the substance or mixture
Sodium oxides
5.3 Advice for firefighters
Self-contained breathing apparatus is recommended in all chemical fire situations.
Section 6 Accidental Release Measures
6.1 Personal precautions, protective equipment and emergency procedures
All components:
Use personal protective equipment. Avoid breathing vapors, mist or gas. Ensure adequate
ventilation. Evacuate personnel to safe areas. For personal protection see section 8.
Standards (S0, S1, S2, S3, S4 and S5):
Product contains material of human and animal origin and should be considered potentially
infectious.
Controls (C1 and C2):
Product contains material of human and animal origin and should be considered potentially
infectious.
RTU plate:
Product contains material of human and animal origin and should be considered potentially
infectious.
6.2 Environmental precautions
Do not let product enter drains.
6.3 Methods and materials for containment and cleaning up
Standards (S0, S1, S2, S3, S4 and S5):
As a precautionary measure, treat spilled material with a 1:10 bleach water solution. Absorb liquid
and place in container suitable for disposal. Avoid generation of aerosols during clean up. Comply
with applicable waste disposal regulations.
Controls (C1 and C2):
As a precautionary measure, treat spilled material with a 1:10 bleach water solution. Absorb liquid
and place in container suitable for disposal. Avoid generation of aerosols during clean up. Comply
with applicable waste disposal regulations.
RTU plate:
As a precautionary measure, treat spilled material with a 1:10 bleach water solution. Absorb liquid
and place in container suitable for disposal. Avoid generation of aerosols during clean up. Comply
with applicable waste disposal regulations.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Activator 1:
Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed
containers for disposal. Avoid generation of aerosols during clean up. Comply with applicable waste
disposal regulations.
Activator 2:
Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed
containers for disposal. Avoid generation of aerosols during clean up. Comply with applicable waste
disposal regulations.
Wash solution:
Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed
containers for disposal. Avoid generation of aerosols during clean up. Comply with applicable waste
disposal regulations.
6.4 Reference to other sections
For disposal see section 13.
Section 7 Handling and Storage
7.1 Precautions for safe handling
Avoid contact with eyes or skin. Avoid inhalation of vapor or mist. Do not eat, drink or smoke during
handling this product. Wash hands after handling. This product should be handled as tough capable
of transmitting infectious diseases. For further precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilities
For storage temperatures see product label. Containers which are opened must be carefully resealed
and kept upright to prevent leakage. The activators should be stored unopened in the original vials in
a dry and well-ventilated place. Keep away from incompatible materials see section 10.5
7.3 Specific end use(s)
Apart from the uses mentioned in section 1.2 no other specific uses are defined.
Section 8 Exposure controls and personal protection
8.1 Control parameters
Not applicable
8.2 Exposure controls
Engineering Controls
Handle in accordance with good industrial hygiene and safety practice.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Personal protecting equipment
Respiratory Protection:
Under normal conditions of use, as mentioned in section 1.2, the use of this product should
not require respiratory protection.
Eye Protection:
Tightly fitting safety goggles. Face shield (8-inch minimum). Use equipment for eye protection tested
and approved under appropriate government standards such as NIOSH (US) or EN
166(EU).
Skin Protection:
Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique
(without touching glove's outer surface) to avoid skin contact with this product. Dispose of
contaminated gloves after use in accordance with applicable laws and good laboratory practices.
Wash and dry hands.
The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the
standard EN 374 derived from it.
Full contact and splash contact:
Material: Nitrile rubber
Minimum layer thickness: 0,11 mm
8.3 Environmental exposure controls
See section 6.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Section 9 Physical and Chemical Properties
Appearance:
Standards (S0, S1, S2, S3, S4 and S5):
Controls (C1 and C2):
Wash solution:
Activator 1:
Activator 2:
RTU plate:
NC plate:
Odor:
Odor Threshold:
pH:
Melting point/Freezing Point:
Boiling Point/Boiling range:
Flash Point:
Evaporation rate:
Flammability (Solid, Gas):
Upper/lower flammability or explosion limits:
Vapor Pressure:
Vapor Density:
Relative density:
Solubility:
Partition coefficient of Water/Oil:
Auto-ignition Temp.:
Decomposition Temp.:
Viscosity:
Explosive properties:
Oxidizing properties:
Freeze dried
Freeze dried
Clear liquid, colorless
Clear liquid, colorless
Clear liquid, colorless
Coated plate containing accuspheres
Non coated empty plate
No data available
No data available
No data available
No data available
No data available
No data available
No data available
Not applicable
No data available
No data available
No data available
No data available
Standards (S0, S1, S2, S3, S4 and S5) and
controls (C1 and C2) are soluble in water.
No data available
No data available
No data available
No data available
No data available
No data available
Section 10 Stability and reactivity
10.1 Reactivity
See subsection 10.3
10.2 Stability
Stable under normal temperatures and pressures.
10.3 Possibility of hazardous reactions
Wash solution:
Sodium azide forms explosive compounds with heavy metals. This product contains <1% (w/w) which
with repeated contact with lead and copper commonly found in plumbing drains may result in the
buildup of shock sensitive compounds.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
Activator 1:
Strong acids; Strong bases; Strong oxidizers
10.4 Conditions to avoid
Avoid contact with incompatible materials, see subsection 10.5.
10.5 Incompatible materials
Wash solution:
Heavy metals such as lead and copper see subsection 10.3.
Activator 1:
Water, acids, Organic materials, Chlorinated solvents, Aluminum, Phosphorus, Tin/tin oxides, Zinc.
10.6. Hazardous Decomposition Products
No decomposition products posing significant hazards would be expected from this product.
Section 11 Toxicological Information
11.1. Information on toxicological effects
Acute Toxicity :
No data available
Skin corrosion and irritation:
No data available
Serious eye damage/irritation:
No data available
Respiratory or skin sensitization:
No data available
Germ cell mutagenicity:
No data available
Carcinogenicity:
No component in this product is listed as carcinogen.
Reproductive toxicity:
No data available
Specific target organ toxicity - single exposure:
No data available
Specific target organ toxicity - repeated exposure:
No data available
Aspiration hazard:
No data available
Primary routes of exposure:
Common routes of entry include inhalation, ingestion and eye/skin contact. Specific paths of concern
for potentially infectious materials are skin puncture, contact with broken skin, contact with mucous
membranes and inhalation of aerosolized material.
Additional Information:
This product contains materials of human and animal origin and should be considered potentially
infectious
Section 12 Ecological Information
12.1 Toxicity
No information available.
12.2 Persistence and degradability
No information available.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
12.3 Bio accumulative potential
No information available.
12.4 Mobility in soil
No information available.
12.5. Results of PBT and vPvB assessment
No information available.
12.6 Other Adverse Effects
No information available.
Section 13 Disposable Considerations
13.1. Waste treatment methods
Dispose of waste product, unused product and contaminated packaging in compliance with federal,
state and local regulations. If unsure of the applicable requirements, contact the authorities for
information.
Section 14 Transport regulations
Sodium hydroxide
UN
number
Transport
hazard
class
PG
UN Proper shipping name
Environmental
hazard
IATA
1824
8
II
Sodium hydroxide solution
No
ADR/RID
1824
8
II
Sodium hydroxide solution
Marine
pollutant: No
IMDG
1824
8
II
Sodium hydroxide solution
No
Section 15 Regulatory Information
This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.
15.1 Safety, health and environmental regulations/legislation specific for the
substance or mixture
Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro
diagnostic medical devices.
No component in this product is listed as carcinogen, mutagenic or reproductive toxic.
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Safety Data Sheet
STAT-IO-I-PTH 4K-IPT-00
Version 8
Publication date: 4/1/2016
15.2 Chemical safety assessment
No chemical safety assessment has been carried out for this mixture by the supplier.
Section 16 Other Information
Complete text of the H-phrases as mentioned in section 2 and 3
H314: Causes severe skin burns and eye damage
Indications of changes
Safety data sheet complemented with hazard information activator 1 and activator 2.
Further information
The above information is believed to be correct but does not purport to be all inclusive and shall be
used only as a guide. The information in this document is based on the present state of our
knowledge and is applicable to the product with regard to the appropriate safety precautions. It does
not represent any guarantee of the properties of this product. Future Diagnostics Solutions B.V. shall
not be held liable for any damage resulting from handling or contact with the above product. The
burden of safe use of these materials rests solely with the user.
Copyright 2016 Future Diagnostics Solutions B.V.
License granted to make unlimited paper copies for internal use only.
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